The new Medical Devices Regulation (MDR) comes into force in May 2020 and represents a big shift in the regulatory framework governing medical devices. Software businesses could be particularly affected by the changes to regulation. Whilst many technology companies find their software is already considered to be a medical device under the regulations, the new guidelines could lead to changes in the classification for a large number of healthtech products.
The importance of complying with the guidelines cannot be overstated. Without the correct certification, software classified as a medical device under the regulations could be prohibited in both a post-Brexit UK and the EU market.
techUK are hosting a joint session with the MHRA to increase knowledge around software as a medical device and awareness of the forthcoming changes. Technology companies who may be affected are invited to attend to help them consider the requirements of the new legislation and understand the barriers to achieving compliance with MDR in time.